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Home > Medications (Drugs) > Gliclazide > More information about Gliclazide

More information about Gliclazide


(GLYE kla zide)

Generic Available

Yes: 80 mg tablet

Canadian Brand Names

Apo-Gliclazide®; Diamicron®; Diamicron® MR; Novo-Gliclazide


Management of type 2 diabetes mellitus (noninsulin dependent, NIDDM)


Not available in U.S.

Pregnancy Risk Factor

Not available (similar agents rated C); manufacturer contraindicates use

Pregnancy Implications

Clinical effects on the fetus: Crosses the placenta. Hypoglycemia; ear defects reported with sulfonylureas; other malformations reported but may have been secondary to poor maternal glucose control/diabetes. Insulin is the drug of choice for the control of diabetes mellitus during pregnancy.


Excretion in breast milk unknown/contraindicated


Hypersensitivity to gliclazide, sulfonylureas, or any component of the formulation; type 1 diabetes mellitus (insulin dependent, IDDM), diabetic ketoacidosis with or without coma; renal or hepatic impairment; pregnancy (per manufacturer); breast-feeding


All sulfonylurea drugs are capable of producing severe hypoglycemia. Hypoglycemia is more likely to occur when caloric intake is deficient, after severe or prolonged exercise, when ethanol is ingested, or when more than one glucose-lowering drug is used. Hypoglycemia is also more likely in elderly patients, or in impaired renal or hepatic function.

Chemical similarities are present among sulfonamides, sulfonylureas, carbonic anhydrase inhibitors, thiazides, and loop diuretics (except ethacrynic acid). Use in patients with sulfonamide allergy is specifically contraindicated in product labeling, however, a risk of cross-reaction exists in patients with allergy to any of these compounds; avoid use when previous reaction has been severe. Safety and efficacy have not been established in pediatric patients.

Product labeling of sulfonylureas (in U.S.) states oral hypoglycemic drugs may be associated with an increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. Data to support this association are limited, and several studies, including a large prospective trial (UKPDS), have not supported an association.

Adverse Reactions

Frequency not defined.

Central nervous system: Headache, nervousness, dizziness

Dermatologic: Rash, erythema, pruritus, urticaria. Sulfonylureas have also been associated with rare photosensitivity and porphyria cutanea tarda

Endocrine & metabolic: Hypoglycemia (dose dependent), hyponatremia (rare)

Gastrointestinal: Nausea, vomiting, diarrhea, epigastric fullness, gastritis

Hematologic: Agranulocytosis, leukopenia, thrombocytopenia, anemia

Hepatic: Jaundice, LDH increased, transaminases increased

Miscellaneous: Disulfiram reaction (very low potential)


Symptoms of overdose include severe hypoglycemia, seizures, cerebral damage, tingling of lips and tongue, nausea, yawning, confusion, agitation, tachycardia, sweating, convulsions, stupor, and coma. Intoxication with sulfonylureas can cause hypoglycemia and is best managed with glucose administration (oral for milder hypoglycemia or by injection in more severe forms).

Drug Interactions

ACE inhibitors: May increase the hypoglycemic effect of gliclazide; monitor

Anabolic steroids: May increase hypoglycemic effect of gliclazide; monitor

Beta-blockers: Decrease hypoglycemic effect, mask most hypoglycemic symptoms, decrease glycogenolysis; avoid use in diabetics with frequent hypoglycemic episodes.

Corticosteroids: May cause hyperglycemia; adjustment of hypoglycemic agent may be necessary.

Cyclosporine: Gliclazide may increase serum concentrations of cyclosporine.

Fluoroquinolones: A possible interaction between sulfonylureas and fluoroquinolone antibiotics has been reported resulting in a potentiation of hypoglycemic action of sulfonylureas.

H2 antagonists, antacids, oral sodium bicarbonate: May increase the hypoglycemic effect; monitor glucose response.

Rifampin: May increase metabolism of gliclazide, decreasing its effects.

Salicylates: May increase hypoglycemic effect of gliclazide.

Sulfonamides: May increase hypoglycemic effect of gliclazide.

Thiazide diuretics: Hypoglycemic effect of gliclazide may be decreased by thiazide diuretics.

Warfarin: Anticoagulant effects may be increased by sulfonylureas.

Ethanol/Nutrition/Herb Interactions

Ethanol: Avoid ethanol (may cause hypoglycemia and/or rare disulfiram reactions).

Herb/Nutraceutical: Avoid chromium, garlic, gymnema (may cause hypoglycemia).


Store at 20°C to 30°C (68°F to 86°F).

Mechanism of Action

Stimulates insulin release from the pancreatic beta cells; reduces glucose output from the liver; lowers plasma glucose concentrations. Gliclazide has also been shown to decrease platelet aggregation at therapeutic doses.


Absorption: Rapid

Protein binding: 94%

Metabolism: Hepatic, to inactive metabolites

Half-life elimination: 10 hours

Time to peak: 4-6 hours

Excretion: Urine (60% to 70%) and feces (10% to 20%) as metabolites


Oral: Adults:

Immediate release tablet: Initial: 80-160 mg/day; typical dose range 80-320 mg/day; dosage of

160 mg should be divided into 2 equal parts for twice-daily administration; maximum dose: 320 mg/day; should be taken with meals

Sustained release tablet: 30-120 mg once daily

Note:   There is no fixed dosage regimen for the management of diabetes mellitus with gliclazide or any other hypoglycemic agent. Dose must be individualized based on frequent determinations of blood glucose during dose titration and throughout maintenance.

Dosage adjustment in renal/hepatic impairment:   Contraindicated in severe impairment


Patients who are anorexic or NPO, may need to have their dose held to avoid hypoglycemia. Should be administered with meals.

Monitoring Parameters

Signs and symptoms of hypoglycemia, fasting blood glucose, hemoglobin A1c

Reference Range

Target range: Adults:

Fasting blood glucose: <120 mg/dL

Glycosylated hemoglobin: <7%

Dietary Considerations

Should be taken with meals. Dietary modification based on ADA recommendations is a part of therapy. Decreases blood glucose concentration. Hypoglycemia may occur. Must be able to recognize symptoms of hypoglycemia (palpitations, sweaty palms, lightheadedness).

Patient Education

This medication is used to control diabetes; it is not a cure. Other components of treatment plan are important: follow prescribed diet, medication, and exercise regimen. Take exactly as directed; with meal(s) at the same time each day. Do not change dose or discontinue without consulting prescriber. Avoid alcohol while taking this medication; could cause severe reaction. Inform prescriber of all other prescription or OTC medications you are taking; do not introduce new medication without consulting prescriber. Do not take other medication within 2 hours of this medication unless advised by prescriber. If you experience hypoglycemic reaction, contact prescriber immediately. Maintain regular dietary intake and exercise routine and always carry quick source of sugar with you. You may be more sensitive to sunlight (use sunscreen, wear protective clothing and eyewear, and avoid direct sunlight). You may experience side effects during first weeks of therapy (headache, nausea); consult prescriber if these persist. Report severe or persistent side effects, extended vomiting or flu-like symptoms, skin rash, easy bruising or bleeding, or change in color of urine or stool. Pregnancy/breast-feeding precautions:   Inform prescriber if you are or intend to become pregnant. Do not breast-feed.

Additional Information

Not available in U.S.

Cardiovascular Considerations

The possibility of higher doses of sulfonylureas eliciting an increase in cardiovascular events, because of their effects on blocking potassium sensitive ATP channels, has been raised. However, there are presently only limited data to support this premise, particularly with newer generation agents. An early study suggested poor cardiovascular outcomes in diabetic patients treated with tolbutamide. Retrospective studies evaluating cardiovascular outcomes following angioplasty and acute myocardial infarction in diabetic patients receiving newer sulfonylureas are inconsistent. Longer-term prospective trials of sulfonylurea therapy, such as the UKPDS, do not reveal any increased cardiovascular mortality.

Dental Health: Effects on Dental Treatment

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Effects on Mental Status

May cause nervousness and dizziness

Mental Health: Effects on Psychiatric Treatment

May cause leukopenia, thrombocytopenia, and agranulocytosis; use caution with clozapine, carbamazepine, and valproic acid

Dosage Forms

Tablet (Diamicron®): 80 mg

Tablet, sustained release (Diamicron® MR): 30 mg

International Brand Names

Aglucide® (AR); Apo-Gliclazide® (CA, NZ); Betanorm® (TR); Cadicon® (TH); Comprid® (BD); Diabeside® (TH); Diabest® (RU); Diabeton® (RU); Diabezidum® (PL); Diabrezide® (AT, IE, IT, PL, RO); Diaclide® (IE); Diactin® (BD); Diaglyk® (GB); Diaklat® (PL); Diamaze® (TH); Diamexon® (TH); Diamicron® (AR, AT, AU, BE, BR, CA, CH, CO, CR, CZ, DE, DK, DO, EG, ES, FR, GB, GT, HK, HN, ID, IE, IN, IT, JO, KW, LB, LU, MT, NL, NZ, PA, PT, SG, SV, SY, TH, TR, ZA); Diamicron® MR (CA); Dianid® (TH); Diaprel® (CZ, HR, HU, PL, RO, SI, YU); Diatrol® (BD); Diazidan® (PL); Glibet® (ID); Glicab® (ID); Gliclazida® (BR, CO); Gliclazida Irex® (PT); Gliclazide Alpharma ApS® (SG); Gliclazide Edmond® (IT); Gliclazide® (GB, PL, RU); Gliclazide Molteni® (IT); Gliclazide Teva® (IT); Glicron® (TH); Glidabet® (ID); Glidiet® (RO); Glikamel® (ID); Gliklazyd® (PL); Glikosan® (YU); Glimicron® (JP, SG); Glinormax® (PL); Glioral® (YU); Glipicrone® (RO); Glizid® (BD); Glucocron® (TH); Glucodex® (ID); Glucozid® (BD); Glucozide® (SG); Gluctam® (HU, PL); Glumeco® (ID); Glumikron® (TR); Glyade® (AU); Glycafor® (ID); Glycon® (TH); Glygard® (ZA); Gored® (BD, ID); Lycazid® (IN); Medoclazide® (RO, SG, TH); Melicron® (SG); Melizide® (SG); Merck-Gliclazide® (BE); Norsulin® (PL); Novo-Gliclazide (CA); Nufamicron® (ID); Oramikron® (TR); Pedab® (ID); Predian® (RU, YU); S.C.D. Glyclazide® (SG); Serviclazide® (TH); Tiaglib® (ID); Unava® (AR); Uni Diamicron® (BE); Xepabet® (ID); Zibet® (ID); Ziclin® (ZA); Zumadiac® (ID); Zumamet® (ID)